Alcohol use disorder: Oral: 666 mg 3 times daily; lower doses (eg, 666 mg 2 times daily) may be considered in patients weighing <60 kg (Rösner 2010; WFSBP [Soyka 2017]). Note: Treatment should be initiated as soon as possible following the period of alcohol withdrawal when the patient has achieved abstinence and should be maintained if patient relapses.
CrCl 30 to 50 mL/minute: Initial dose: 333 mg 3 times daily. Note: The American Psychiatric Association alcohol use disorder guidelines recommend that acamprosate should not be used first-line for patients with mild to moderate renal impairment (APA [Reus 2018]).
CrCl ≤30 mL/minute: Use is contraindicated.
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Delayed Release, Oral, as calcium:
Generic: 333 mg
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Delayed Release, Oral, as calcium:
Campral: 333 mg
Oral: May be administered without regard to meals (administered with meals during clinical trials to possibly increase compliance). Tablet should be swallowed whole; do not crush or chew.
Bariatric surgery: Tablet, delayed release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. No IR formulation available.
Alcohol use disorder: Maintenance of abstinence from alcohol in patients with alcohol use disorder who are abstinent at treatment initiation, as part of a comprehensive management program
Limitations of use: Efficacy has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning treatment. Efficacy in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Many adverse effects associated with treatment may be related to alcohol abstinence; reported frequency range may overlap with placebo.
>10%: Gastrointestinal: Diarrhea (10% to 17%)
1% to 10%:
Cardiovascular: Chest pain, hypertension, palpitations, peripheral edema, syncope, vasodilation
Central nervous system: Insomnia (6% to 9%), anxiety (5% to 8%), depression (4% to 8%), dizziness (3% to 4%), pain (2% to 4%), paresthesia (2% to 3%), abnormality in thinking, amnesia, chills, drowsiness, headache, suicidal tendencies
Dermatologic: Pruritus (3% to 4%), diaphoresis (2% to 3%), skin rash
Endocrine & metabolic: Decreased libido, weight gain
Gastrointestinal: Anorexia (2% to 5%), nausea (3% to 4%), flatulence (1% to 4%), xerostomia (1% to 3%), abdominal pain, constipation, dysgeusia, dyspepsia, increased appetite, vomiting
Genitourinary: Impotence
Infection: Infection
Neuromuscular & skeletal: Weakness (5% to 7%), arthralgia, back pain, myalgia, tremor
Ophthalmic: Visual disturbance
Respiratory: Bronchitis, dyspnea, flu-like symptoms, increased cough, pharyngitis, rhinitis
<1%, postmarketing, and/or case reports: Abnormal hepatic function tests, agitation, alopecia, anemia, angina pectoris, asthma, brain disease, colitis, confusion, deafness, diabetes mellitus, duodenal ulcer, eosinophilia, epistaxis, exfoliative dermatitis, fever, gastrointestinal hemorrhage, gout, hallucination, hemorrhage, hepatic cirrhosis, hepatitis, hostility, hyperbilirubinemia, hyperesthesia, hyperglycemia, hypersensitivity reaction, hyperuricemia, hyponatremia, hypotension, hypothyroidism, increased serum creatinine, increased serum transaminases, leukopenia, lymphadenopathy, lymphocytosis, myocardial infarction, nephrolithiasis, neuralgia, ophthalmic inflammation, orthostatic hypotension, pancreatitis, pneumonia, psychoneurosis, psychosis, pulmonary embolism, rectal hemorrhage, renal failure, seizure, skin photosensitivity, suicidal ideation, tachycardia, thrombocytopenia, urticaria, withdrawal syndrome
Hypersensitivity to acamprosate or any component of the formulation; severe renal impairment (CrCl ≤30 mL/minute)
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).
• Suicidal thinking/behavior: Attempted and completed suicides have occurred in acamprosate-treated patients; use with caution in suicidal ideation. Monitor for depression and/or suicidal thinking.
Disease-related concerns:
• Alcohol use disorder: Appropriate use: Should be used as part of a comprehensive program to treat alcohol use disorder. Treatment should be initiated as soon as possible following the period of alcohol withdrawal, when the patient has achieved abstinence. Acamprosate does not eliminate or diminish the symptoms of alcohol withdrawal.
• Renal impairment: Use with caution and reduce dose in patients with moderate renal impairment (CrCl 30 to 50 mL/minute). Use is contraindicated in patients with severe renal impairment (CrCl ≤30 mL/minute). The American Psychiatric Association alcohol use disorder guidelines recommend that acamprosate should not be used first-line for patients with mild to moderate renal impairment. (APA [Reus 2018]).
Dosage form specific issues:
• Sulfites: Traces of sulfites may be present in the formulation.
None known.
There are no known significant interactions.
Food decreases absorption of acamprosate (not clinically significant). Management: Administer without regard to meals.
Adverse events were observed in animal reproduction studies.
Pharmacological agents should not be used for the treatment of alcohol use disorder in pregnant women unless needed for the treatment of acute alcohol withdrawal or a coexisting disorder; agents other than acamprosate are recommended for acute alcohol withdrawal (APA [Reus 2018]).
It is not known if acamprosate is present in breast milk. The manufacturer recommends that caution be exercised when administering acamprosate to breastfeeding women. Pharmacological agents should not be used for the treatment of alcohol use disorder in breastfeeding women unless needed for the treatment of acute alcohol withdrawal or a coexisting disorder; agents other than acamprosate are recommended for acute alcohol withdrawal (APA [Reus 2018]).
Abstinence is required for initiation of treatment; however, treatment should be continued in the event of a relapse.
Renal function (baseline; as clinically indicated); weight (baseline; as clinically indicated); suicidal ideation.
Mechanism not fully defined. Structurally similar to gamma-amino butyric acid (GABA), acamprosate appears to increase the activity of the GABA-ergic system, and decreases activity of glutamate within the CNS, including a decrease in activity at N-methyl D-aspartate (NMDA) receptors; may also affect CNS calcium channels. Restores balance to GABA and glutamate activities which appear to be disrupted in alcohol use disorder. During therapeutic use, reduces alcohol intake, but does not cause a disulfiram-like reaction following alcohol ingestion. Insignificant CNS activity, outside its effect on alcohol use disorder, was observed including no anxiolytic, antiseizure, or antidepressant activity.
Distribution: Vd: ~1 L/kg
Protein binding: Negligible
Metabolism: Not metabolized
Bioavailability: ~11%
Half-life elimination: 20 to 33 hours; 1.8- and 2.6-fold longer in patients with moderate or severe renal impairment
Time to peak, plasma: 3 to 8 hours
Excretion: Urine (as unchanged drug)
Renal function impairment: Cmax in patients with moderate or severe renal impairment were 2- and 4-fold higher, respectively.
Tablet, EC (Acamprosate Calcium Oral)
333 mg (per each): $1.39 - $2.71
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